NCT03998007已完成不适用
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PainQx, Inc
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)
研究概览
简要总结
Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female chronic pain patients
- •Patients between the ages of 18-85 years
- •Patients exhibiting the presence of symptoms in excess of 3 months duration
- •Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
- •Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)
- •Patients with NRS pain scores across the full range (1-10) at the time of testing
排除标准
- •Patients with medically diagnosed psychotic illness
- •Patients with medically diagnosed drug or alcohol dependence in the past 12 months
- •Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
- •Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
- •Patients who have a spinal cord stimulator, or other implantable devices
- •Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain
- •Patients with cancer
- •Patients on workers compensation or disability
- •Patient on anticonvulsant medication
- •Patients who have a history of seizures
结局指标
主要结局
Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)
时间窗: 6 Months
A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables
次要结局
未报告次要终点
研究者
研究点 (1)
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